Pharmaceuticals

Last Updated on February 24, 2022

Following guidelines are intended to help the industry and other applicants to meet the regulatory requirements related to the pharmaceuticals products.

1. Registration Process

Guidance Document For Submission Of Application On FORM 5-F (CTD) For Registration Of Pharmaceutical Drug Products For Human Use .
English ( 444 KB – PDF)

Guidance on Preparation of Summary of Product Characteristics (SmPC)
English ( 479 KB – PDF)

Frequently asked questions about Form 5F (Common Technical Documents)
English ( 256 KB – PDF)

2. Post Approval Variation

Post Registration Variation Guidelines For Pharmaceutical and Biological Products
English ( 610 KB – PDF)

3. Non Routine Registration pathways

Priority Review and Accelerated Approval of Registration / Market Authorization
English ( 426 KB – PDF)

4. Reliance Mechanism

Reliance Mechanism in Regulatory processes, A DRAP’s approach on Good Reliance Practices
English ( 454 KB – PDF)

5. Appeals Against Regulatory Decisions

Guidelines for Filling an Appeal Against the Decisions of Statutory Bodies (e.g. Registration Board)
English ( 371 KB – PDF)